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Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study

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ClinicalTrials.gov Identifier: NCT03652623
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Hektoen Institute for Medical Research

Brief Summary:

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented.

The project has the following important specific aims:

Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure.

Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. The investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board.

Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.


Condition or disease Intervention/treatment Phase
HIV/AIDS Gender Behavior and Behavior Mechanisms Drug: TDF/FTC Phase 1 Phase 2

Detailed Description:

Transgender women (TW) are one of the most vulnerable populations for acquiring HIV infection, and the scant available data on transgender men (TM) suggests they are also at risk. TW have accounted for only 0.2% of all participants in bio-behavioral HIV prevention trials using pre-exposure prophylaxis (PrEP), and TM have typically not been included. TW and TM adolescents have received even less attention in PrEP trials.

Although tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), the FDA-approved PrEP drug, would not be expected to interact with cross-sex hormone therapy (cs-HT; estradiol and testosterone) based on known mechanisms and data from studies with hormonal contraceptives, there are no data that prove this. Given this lack of data, TW and TM youth on cs-HT have decreased PrEP uptake and adherence due to concerns that PrEP may reduce the effectiveness of cs-HT. To address these critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation, the investigators propose the following study in 3 integrated phases. In Phase 1, the investigators will conduct a PK study exploring the interactions of cs-HT for both TW and TM on TDF/FTC. Simultaneously, in Phase 2, the investigators will collect ethnographic data via focus groups and in-depth interviews to inform the development of a tailored gender-affirmative intervention to improve uptake and adherence to PrEP in transgender youth. In Phase 3, the investigators will conduct a small demonstration trial of PrEP use in TW and TM youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transgender Youth and PrEP: PK, Safety, Uptake & Adherence
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TDF/FTC and cs-HT
Transgender youth will simultaneously take TDF/FTC and cs-HT. TW will take oral estradiol +/- spironolactone and TM will take subcutaneous testosterone. In order to ensure adherence to TDF/FTC, daily DOT procedures will be employed.
Drug: TDF/FTC
In Phase 1, a PK study will be conducted to evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among transgender women taking estradiol and transgender men taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily TDF/FTC adherence and maximize drug exposure.




Primary Outcome Measures :
  1. Change in Tenofovir Levels [ Time Frame: Baseline and Weeks 0, 1, 2, 3 & 4 ]
    Tenofovir levels in a cohort of transgender youth on cs-HT

  2. Change in Estradiol Levels [ Time Frame: Baseline and Weeks 0, 1, 2, 3 & 4 ]
    Estradiol levels in a cohort of transgender youth on cs-HT

  3. Change in Testosterone Levels [ Time Frame: Baseline and Weeks 0, 1, 2, 3 & 4 ]
    Testosterone levels in a cohort of transgender youth on cs-HT



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identification as a transgender individual
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identification as a transgender individual [As determined by the two-step process of gender identification whereby potential participants will be asked their gender identity and sex assigned at birth]
  • HIV-uninfected by EIA and viral load within 7 days of study entry
  • Creatinine clearance ≥ 60 mL/min by Cockroft Gault for ages ≥18 years (Schwartz equation for those <18)
  • Willing to comply with all study procedures
  • On a stable dose of cs-HT for at least 2 months verified by clinical chart review and willing to not change doses for duration of PK study

Exclusion Criteria:

  • Hospitalization within 30 days of study entry (elective procedures okay with team approval)
  • Condition (medical, psychological, or social) that, in the opinion of the study investigators, would preclude the participant from completing study-required procedures
  • Previous participation in an HIV vaccine study, unless the participant can document placebo arm assignment
  • Use of TDF/FTC in the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652623


Contacts
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Contact: Sybil Hosek, PhD 3128648030 shosek@cookcountyhhs.org
Contact: Jennifer Brothers, MPH 3128648008 jbrothers@cookcountyhhs.org

Locations
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United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Daniel Reirden, MD    720-777-4971    daniel.reirden@coloradochildrens.org   
Sponsors and Collaborators
Hektoen Institute for Medical Research
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sybil Hosek, PhD John H. Stroger Hospital

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Responsible Party: Hektoen Institute for Medical Research
ClinicalTrials.gov Identifier: NCT03652623     History of Changes
Other Study ID Numbers: R01MH114753-1
R01MH114753 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hektoen Institute for Medical Research:
Transgender
Pre-exposure Prophylaxis (PrEP)
HIV Prevention
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
Cross-sex Hormone Therapy
Adherence
Behavior Change
Gender Affirmation